510(k) Report

FDA applicant

Ics of North America, Inc.

San Diego, CA2 decisions1999–19990 recalls

FDA records 2 decisions for Ics of North America, Inc. (San Diego, CA) in 1999: 2 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and EBZ (Activator, Ultraviolet, For Polymerization). Its devices cite 8 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Ics of North America, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ics of North America, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ics of North America, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument1decision
  • EBZActivator, Ultraviolet, For Polymerization1decision

Whose devices does it build on?

Its devices cite 8 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K992357Easy-Cure (Curing and Whitening Light)Ics of North America, Inc. · 1999
  • K983654Cyber-Lase 2000 Curing and Whitening LaserIcs of North America, Inc. · 1999

All 2 as Ics of North America, Inc. →